Alprazolam
- Product NDC
- 58118-0679
- 11-digit product format
- 581180679
- Labeler code
- 58118
- Product ID
- 58118-0679_57af6374-250e-6605-e063-6394a90a7df7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Alprazolam
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Clinical Solutions Wholesale, LLC
- Application
- ANDA203346
- Marketing category
- ANDA
- Marketing start
- 2015-07-31
- Substance
- ALPRAZOLAM
- Active strength
- 2 mg/1
- Pharmacologic classes
- Benzodiazepine [EPC], Benzodiazepines [CS]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A203346-001 | ALPRAZOLAM | ALPRAZOLAM | 0.25MG | TABLET / ORAL | AB | 2015-07-31 | |
| A203346-002 | ALPRAZOLAM | ALPRAZOLAM | 0.5MG | TABLET / ORAL | AB | 2015-07-31 | |
| A203346-003 | ALPRAZOLAM | ALPRAZOLAM | 1MG | TABLET / ORAL | AB | 2015-07-31 | |
| A203346-004 | ALPRAZOLAM | ALPRAZOLAM | 2MG | TABLET / ORAL | AB | 2015-07-31 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A203346-001 | AB |
| A203346-002 | AB |
| A203346-003 | AB |
| A203346-004 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A203346-001 | ALPRAZOLAM | 0.25MG | TABLET / ORAL | AB | 2015-07-31 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A203346-002 | ALPRAZOLAM | 0.5MG | TABLET / ORAL | AB | 2015-07-31 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A203346-003 | ALPRAZOLAM | 1MG | TABLET / ORAL | AB | 2015-07-31 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A203346-004 | ALPRAZOLAM | 2MG | TABLET / ORAL | AB | 2015-07-31 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A203346-001 | ALPRAZOLAM | 0.25MG | TABLET / ORAL | AB | 2015-07-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A203346-002 | ALPRAZOLAM | 0.5MG | TABLET / ORAL | AB | 2015-07-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A203346-003 | ALPRAZOLAM | 1MG | TABLET / ORAL | AB | 2015-07-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A203346-004 | ALPRAZOLAM | 2MG | TABLET / ORAL | AB | 2015-07-31 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203346-001 | ALPRAZOLAM | 0.25MG | TABLET / ORAL | AB | 2015-07-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203346-002 | ALPRAZOLAM | 0.5MG | TABLET / ORAL | AB | 2015-07-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203346-003 | ALPRAZOLAM | 1MG | TABLET / ORAL | AB | 2015-07-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203346-004 | ALPRAZOLAM | 2MG | TABLET / ORAL | AB | 2015-07-31 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203346-001 | ALPRAZOLAM | 0.25MG | TABLET / ORAL | AB | 2015-07-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203346-002 | ALPRAZOLAM | 0.5MG | TABLET / ORAL | AB | 2015-07-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203346-003 | ALPRAZOLAM | 1MG | TABLET / ORAL | AB | 2015-07-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203346-004 | ALPRAZOLAM | 2MG | TABLET / ORAL | AB | 2015-07-31 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203346-001 | ALPRAZOLAM | 0.25MG | TABLET / ORAL | AB | 2015-07-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203346-002 | ALPRAZOLAM | 0.5MG | TABLET / ORAL | AB | 2015-07-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203346-003 | ALPRAZOLAM | 1MG | TABLET / ORAL | AB | 2015-07-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203346-004 | ALPRAZOLAM | 2MG | TABLET / ORAL | AB | 2015-07-31 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203346-001 | ALPRAZOLAM | 0.25MG | TABLET / ORAL | AB | 2015-07-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203346-002 | ALPRAZOLAM | 0.5MG | TABLET / ORAL | AB | 2015-07-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203346-003 | ALPRAZOLAM | 1MG | TABLET / ORAL | AB | 2015-07-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203346-004 | ALPRAZOLAM | 2MG | TABLET / ORAL | AB | 2015-07-31 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203346-001 | ALPRAZOLAM | 0.25MG | TABLET / ORAL | AB | 2015-07-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203346-002 | ALPRAZOLAM | 0.5MG | TABLET / ORAL | AB | 2015-07-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203346-003 | ALPRAZOLAM | 1MG | TABLET / ORAL | AB | 2015-07-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203346-004 | ALPRAZOLAM | 2MG | TABLET / ORAL | AB | 2015-07-31 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203346-001 | ALPRAZOLAM | 0.25MG | TABLET / ORAL | AB | 2015-07-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203346-002 | ALPRAZOLAM | 0.5MG | TABLET / ORAL | AB | 2015-07-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203346-003 | ALPRAZOLAM | 1MG | TABLET / ORAL | AB | 2015-07-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203346-004 | ALPRAZOLAM | 2MG | TABLET / ORAL | AB | 2015-07-31 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203346-001 | ALPRAZOLAM | 0.25MG | TABLET / ORAL | AB | 2015-07-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203346-002 | ALPRAZOLAM | 0.5MG | TABLET / ORAL | AB | 2015-07-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203346-003 | ALPRAZOLAM | 1MG | TABLET / ORAL | AB | 2015-07-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203346-004 | ALPRAZOLAM | 2MG | TABLET / ORAL | AB | 2015-07-31 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203346-001 | ALPRAZOLAM | 0.25MG | TABLET / ORAL | AB | 2015-07-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203346-002 | ALPRAZOLAM | 0.5MG | TABLET / ORAL | AB | 2015-07-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203346-003 | ALPRAZOLAM | 1MG | TABLET / ORAL | AB | 2015-07-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203346-004 | ALPRAZOLAM | 2MG | TABLET / ORAL | AB | 2015-07-31 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A203346-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A203346-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A203346-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A203346-004 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A203346-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A203346-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A203346-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A203346-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A203346-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203346-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203346-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203346-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203346-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203346-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203346-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203346-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A203346-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203346-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203346-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203346-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203346-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203346-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203346-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203346-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203346-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203346-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203346-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203346-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203346-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203346-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203346-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203346-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203346-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203346-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203346-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203346-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203346-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203346-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203346-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203346-004 | AB | 1 | 5bbf6a4d5a75… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Alprazolam
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ALPRAZOLAM | 2 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| YU55MQ3IZY | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0cf8b567-201b-44fa-8fd3-c74023aff44f | Available on FDA.report |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Alprazolam | ALPRAZOLAM | Clinical Solutions Wholesale, LLC | 0cf8b567-201b-44fa-8fd3-c74023aff44f | 2026-07-28 | Boxed warning, Warnings, Adverse reactions | 203346 ANDA203346 58118-0679 |
| Alprazolam | ALPRAZOLAM | PD-Rx Pharmaceuticals, Inc. | 4203d3fe-916e-41af-9daf-f58f4fed6f9c | 2026-07-07 | Boxed warning, Warnings, Adverse reactions | 203346 ANDA203346 |
| Alprazolam | ALPRAZOLAM | St. Mary's Medical Park Pharmacy | fc5fe795-6b41-aecf-e053-6394a90af562 | 2026-06-02 | Boxed warning, Warnings, Adverse reactions | 203346 ANDA203346 |
| Alprazolam | ALPRAZOLAM | Bryant Ranch Prepack | 68d8b8d1-00a4-42c4-a796-90211fee1a6d | 2026-05-20 | Boxed warning, Warnings, Adverse reactions | 203346 ANDA203346 |
| Alprazolam | ALPRAZOLAM | Coupler LLC | 5111e57d-8920-6861-e063-6294a90a2194 | 2026-05-05 | Boxed warning, Warnings, Adverse reactions | 203346 ANDA203346 |
| Alprazolam | ALPRAZOLAM | ASCLEMED USA INC. | 8d76a554-7ed1-4c93-a5ea-30898aec0aa1 | 2026-04-30 | Boxed warning, Warnings, Adverse reactions | 203346 ANDA203346 |
| Alprazolam | ALPRAZOLAM | Coupler LLC | 509a8a86-d61c-3f05-e063-6394a90a52ca | 2026-04-29 | Boxed warning, Warnings, Adverse reactions | 203346 ANDA203346 |
| Alprazolam | ALPRAZOLAM | Bryant Ranch Prepack | 2bd0d4c6-0fde-46f2-bb13-da25d50427df | 2026-04-15 | Boxed warning, Warnings, Adverse reactions | 203346 ANDA203346 |
| Alprazolam | ALPRAZOLAM | Bryant Ranch Prepack | d8364af1-d23e-4cd7-9a81-077ae97a951a | 2026-04-13 | Boxed warning, Warnings, Adverse reactions | 203346 ANDA203346 |
| Alprazolam | ALPRAZOLAM | Bryant Ranch Prepack | 0e2644fa-8334-4209-a63d-2466b5ab55b4 | 2026-04-13 | Boxed warning, Warnings, Adverse reactions | 203346 ANDA203346 |
| Alprazolam C-IV | ALPRAZOLAM C-IV | Direct_Rx | f6dd8005-1d50-41bc-e053-6394a90ac45b | 2026-03-05 | Boxed warning, Warnings, Adverse reactions | 203346 ANDA203346 |
| Alprazolam | ALPRAZOLAM | Proficient Rx LP | c6795ed8-af28-41f4-b85b-48e1fe9d0369 | 2026-03-01 | Boxed warning, Warnings, Adverse reactions | 203346 ANDA203346 |
| Alprazolam | ALPRAZOLAM | PreferredPharmaceuticals Inc. | dc130aae-4510-4de7-a750-4a144e88208d | 2026-02-20 | Boxed warning, Warnings, Adverse reactions | 203346 ANDA203346 |
| Alprazolam | ALPRAZOLAM | Preferred Pharmaceuticals Inc. | 73c1d1dc-ade2-4bb4-b109-83bd63acd15c | 2026-02-19 | Boxed warning, Warnings, Adverse reactions | 203346 ANDA203346 |
| Alprazolam | ALPRAZOLAM | Preferred Pharmaceuticals Inc. | 78682252-e448-4b20-b49d-27c2c70e4cb3 | 2026-02-18 | Boxed warning, Warnings, Adverse reactions | 203346 ANDA203346 |
| Alprazolam | ALPRAZOLAM | Northwind Health Company, LLC | 25174ee5-a86e-ab97-e063-6394a90acd87 | 2025-12-26 | Boxed warning, Warnings, Adverse reactions | 203346 ANDA203346 |
| Alprazolam | ALPRAZOLAM | Aurobindo Pharma Limited | d2fd0b3e-9b78-44d0-82a6-96d6c6238750 | 2025-12-11 | Boxed warning, Warnings, Adverse reactions | 203346 ANDA203346 |
| Alprazolam | ALPRAZOLAM | AvPAK | 3fa14fa4-45a7-6ef4-e063-6394a90a1dcd | 2025-09-25 | Boxed warning, Warnings, Adverse reactions | 203346 ANDA203346 |
| Alprazolam C-IV | ALPRAZOLAM C-IV | Direct_Rx | f6dd0e94-4a79-769f-e053-6394a90a5ae6 | 2025-06-02 | Boxed warning, Warnings, Adverse reactions | 203346 ANDA203346 |
| Alprazolam | ALPRAZOLAM | NuCare Pharmaceuticals, Inc. | 315b5782-969a-4324-e063-6394a90acf37 | 2025-03-27 | Boxed warning, Warnings, Adverse reactions | 203346 ANDA203346 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 58118-0679-8 | 58118067908 | 30 TABLET in 1 BLISTER PACK (58118-0679-8) | 30 tablet | 2026-07-28 | No | No | Current |